Linked Life Data

8298199

Source:http://linkedlifedata.com/resource/pubmed/id/8298199

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
1994-3-10
pubmed:abstractText
Alendronate sodium (ALN) is a potent amino bisphosphonate which specifically inhibits osteoclastic bone resorption and has been found to reverse bone loss in several animal models. To determine if daily oral ALN treatment could prevent or reverse bone loss in osteoporotic postmenopausal women, and to compare ALN to intranasal salmon calcitonin (CT), a 2-year, double-masked, randomized, placebo-controlled study was initiated at 9 clinical centers in Italy. Two hundred and eighty six postmenopausal women (age 48-76) with spinal bone mineral density (BMD) > or = 2 SD below adult mean peak, with or without vertebral crush fractures, were randomized to one of four treatment arms: ALN 10 mg daily, ALN 20 mg daily or matching placebo (these groups all double-masked), or CT 100 IU daily (open label) for 2 years. All patients received supplemental calcium (as carbonate) 500 mg daily. Bone mass was measured by dual-energy X-ray absorptiometry of the PA lumbar spine (LS) and proximal femur (femoral neck and trochanter) at 6-month intervals. Subject safety was measured through sequential clinical and laboratory evaluation. A planned 1-year interim analysis of this ongoing study was performed centrally in a manner that maintains the double-mask for all subjects receiving oral study drug. Relative to PBO, ALN at either 10 mg or 20 mg daily increased LS BMD by 4.7% and 6.1%, respectively; each increased femoral neck BMD by 3.1% and increased trochanter BMD by 3.3% and 3.8% respectively. In contrast, CT failed to significantly increase BMD of either the spine, femoral neck or trochanter, either relative to baseline or to PBO.(ABSTRACT TRUNCATED AT 250 WORDS)
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
0937-941X
pubmed:author
pubmed:issnType
Print
pubmed:volume
3 Suppl 3
pubmed:owner
NLM
pubmed:authorsComplete
N
pubmed:pagination
S21-7
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed:year
1993
pubmed:articleTitle
Treatment of postmenopausal osteoporosis with continuous daily oral alendronate in comparison with either placebo or intranasal salmon calcitonin.
pubmed:affiliation
Istituto di Semeiotica e Nefrologia Medica, Universita di Verona, Italy.
pubmed:publicationType
Journal Article, Clinical Trial, Comparative Study, Randomized Controlled Trial, Multicenter Study